← Back to Search

Microbiome Therapy

Fecal Transplant for C-diff Infection (FMT Trial)

Phase 1
Recruiting
Led By Jonathan M. Gisser, M.D.
Research Sponsored by Jonathan Gisser
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No antibiotic use within the last 90 days
≥ 18 years old
Must not have
On immunosuppressive medications (high dose steroids 30 mg/kg of methylprednisolone)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months post transplant
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a fecal transplant can help treat children with C-diff infection who have not gotten better with other medicines.

Who is the study for?
This trial is for children and young adults aged 2 to less than 21 years with recurrent C-diff infection, who are undergoing a colonoscopy. Participants must have had at least three episodes of this infection. Healthy first-degree relatives over 18 can be donors, but they shouldn't have taken antibiotics recently or have any listed health issues.
What is being tested?
The study tests fecal microbiota transplantation (FMT) in pediatric patients with recurrent C-diff infections. FMT involves transferring stool from a healthy donor into the patient's colon to balance the bacteria and combat the infection.
What are the potential side effects?
Potential side effects may include discomfort at the transplant site, abdominal pain, bloating, diarrhea or constipation following the procedure. There might also be risks related to sedation for colonoscopy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I haven't taken antibiotics in the last 3 months.
Select...
I am 18 years old or older.
Select...
I have had c-diff infection three or more times.
Select...
I am currently experiencing diarrhea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am on high-dose steroids or other immunosuppressive medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Resolution of C. difficile
Secondary study objectives
Adverse events

Side effects data

From 2020 Phase 1 & 2 trial • 50 Patients • NCT03106844
44%
Diarrhea
26%
Abdominal Pain
16%
Rectal Bleeding
12%
Constiption
10%
Fever
10%
Nausea
6%
Fatigue
6%
Vomiting
4%
Heart Burn
4%
Chills
4%
Yeast Infection
4%
Migraine
2%
Anemia
2%
IBD Flare
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Fecal Microbiota TransplantationExperimental Treatment1 Intervention
250 ml of a fecal suspension diluted in saline given by colonoscopy or enema.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fecal Microbiota Transplantation
2020
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

Jonathan GisserLead Sponsor
Jonathan M. Gisser, M.D.Principal InvestigatorNationwide Children's Hospital

Media Library

Fecal Microbiota Transplantation (Microbiome Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02134392 — Phase 1
Clostridium Difficile Research Study Groups: Fecal Microbiota Transplantation
Clostridium Difficile Clinical Trial 2023: Fecal Microbiota Transplantation Highlights & Side Effects. Trial Name: NCT02134392 — Phase 1
Fecal Microbiota Transplantation (Microbiome Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02134392 — Phase 1
~0 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top